Poor
Non-Compliant
Patient Risk:
High
Summary
Several antimicrobial coverage/indication expansion claims are unsupported by the provided label sections and one claim is contradicted (VRE in cSSSI). Multiple other organism/condition claims (e.g., Pseudomonas aeruginosa; Moraxella catarrhalis; bacteremia/sepsis) are not supported by the provided indications/usage language.
Category Scores
Accurate Statements
Tigecycline is structurally related to tetracyclines.
Supported by 11 DESCRIPTION describing tigecycline as a “tetracycline class antibacterial.”
Tigecycline is approved for the treatment of complicated skin and skin structure infections (cSSSI).
Supported by 1 INDICATIONS AND USAGE (1.1).
Tigecycline is approved for the treatment of community-acquired bacterial pneumonia (CABP).
Supported by 1 INDICATIONS AND USAGE (1.3).
Tigecycline is effective against methicillin-resistant Staphylococcus aureus (MRSA) in cSSSI.
Supported because 1.1 includes Staphylococcus aureus (methicillin-susceptible and -resistant isolates).
Tigecycline is effective against Streptococcus pneumoniae in CABP.
Supported by 1.3 (Streptococcus pneumoniae (penicillin-susceptible isolates)).
Tigecycline is effective against Haemophilus influenzae in CABP.
Supported by 1.3 (Haemophilus influenzae).
Tigecycline is effective against Escherichia coli in intra-abdominal infections.
Supported by 1.2 (Escherichia coli listed for complicated intra-abdominal infections).
Tigecycline is effective against Klebsiella pneumoniae in intra-abdominal infections.
Supported by 1.2 (Klebsiella pneumoniae listed for complicated intra-abdominal infections).
Tigecycline is not effective against all types of bacteria.
Supported by 1.1/1.2/1.3 limiting indications to infections caused by susceptible isolates, and by 1.4 limitations of use.
Tigecycline can cause side effects including nausea.
Supported by 6 ADVERSE REACTIONS (6.1) where nausea is among the most common adverse reactions.
Tigecycline can cause side effects including vomiting.
Supported by 6 ADVERSE REACTIONS (6.1) where vomiting is among the most common adverse reactions.
Tigecycline can cause side effects including diarrhea.
Supported by 6 ADVERSE REACTIONS (6.1) Table 1 listing diarrhea incidence.
Unsupported Statements
Tigecycline is a glycylcycline antibiotic.
Not supported by the provided label text; 11 DESCRIPTION does not state “glycylcycline.”
Tigecycline was first approved by the FDA in 2005.
The provided label excerpts do not mention an approval year.
Tigecycline is effective against Pseudomonas aeruginosa in cSSSI.
Pseudomonas aeruginosa is not listed among the susceptible isolates for cSSSI in 1.1.
Tigecycline is effective against Moraxella catarrhalis in CABP.
Moraxella catarrhalis is not listed among the susceptible isolates for CABP in 1.3.
Tigecycline is effective against Pseudomonas aeruginosa in intra-abdominal infections.
Pseudomonas aeruginosa is not listed among the susceptible isolates for complicated intra-abdominal infections in 1.2.
Tigecycline is effective against Staphylococcus aureus in bacteremia and sepsis.
The provided label sections list indications by infection type (cSSSI, cIAI, CABP) and do not support “bacteremia and sepsis” as an indication/condition.
Tigecycline is effective against Enterococcus faecalis in bacteremia and sepsis.
The provided label sections do not support “bacteremia and sepsis” as an indication/condition.
Tigecycline is effective against Pseudomonas aeruginosa in bacteremia and sepsis.
The provided label sections do not support “bacteremia and sepsis” as an indication/condition.
Tigecycline use should be reserved for cases where other antibiotics have failed.
5 WARNINGS AND PRECAUTIONS and 1.4 support reservation when alternative treatments are not suitable, but the specific “have failed” wording is not supported by the provided excerpts.
Contradictions
High
AI Statement
Tigecycline is effective against vancomycin-resistant Enterococcus (VRE) in cSSSI.
Label Reference
1 INDICATIONS AND USAGE (1.1) specifies Enterococcus faecalis (vancomycin-susceptible isolates), not VRE.
Important Omissions
No dosing/administration details were evaluated because the AI response provided no dose or infusion-rate instructions; the label excerpt set includes no dosage section content to confirm.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
High
High-risk mismatch due to a contradicted antimicrobial coverage claim (VRE effectiveness in cSSSI) and unsupported/unlabeled condition expansion claims (bacteremia/sepsis).
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
Yes |
| Promotes Unapproved Use |
Yes |
| Hallucination Risk |
High |
Recommendation
Non-Compliant
Primary Issue
Contradicted VRE effectiveness claim and multiple unsupported/unlabeled expansions to organism coverage and bacteremia/sepsis conditions.
Suggested Improvement
Restrict claims to the label-supported indications/organisms listed under cSSSI (1.1), cIAI (1.2), and CABP (1.3), and avoid asserting coverage for VRE, Pseudomonas aeruginosa (where not listed), Moraxella catarrhalis (where not listed), or bacteremia/sepsis as a labeled condition.